BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3162506 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-06992
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    February 1, 2012
    Report Date
    May 23, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A SLING PROCEDURE IN (B)(6) 2008. THE PATIENT DEVELOPED URINARY TRACT INFECTIONS AND PAIN DURING INTERCOURSE. THE PATIENT STATED THAT SHE WILL BE HAVING A PROCEDURE TO CHECK FOR POSSIBLE EROSION OF THE MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262443 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention